Efficacy Claims & footnotes
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For efficacy claims in promotional pieces, what is the minimum requirement of support required? Can we footnote the supporting data or lead the user to the HCP website where the complete data information can be found?
Or if we include a softer efficacy claim for a product will a CTA to the HCP website suffice?
Thanks
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For efficacy claims in promotional pieces, what is the minimum requirement of support required? Can we footnote the supporting data or lead the user to the HCP website where the complete data information can be found?
Or if we include a softer efficacy claim for a product will a CTA to the HCP website suffice?
Thanks
Hi @joao-borges
Thank you for your question. In general, Code section 3.1 provides direction on requirements for substantiation. Please also see our resource link for types of marketing benefit claims and tips for levels support for each type.
The efficacy claim itself determines whether supporting information is required to appear prominently in the body copy of the APS (rather than a footnote). Linking to an HCP website with the data is generally not acceptable. For fundamentals on substantiating claims and other topics, we also suggest our new PAAB 1.0 training course.
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Hi @joao-borges
Thank you for your question. In general, Code section 3.1 provides direction on requirements for substantiation. Please also see our resource link for types of marketing benefit claims and tips for levels support for each type.
The efficacy claim itself determines whether supporting information is required to appear prominently in the body copy of the APS (rather than a footnote). Linking to an HCP website with the data is generally not acceptable. For fundamentals on substantiating claims and other topics, we also suggest our new PAAB 1.0 training course.
@jennifer-carroll Thank you this was very helpful
